EAR for MDD I (non-measuring, non-sterile) products

An E.A.R. or European Authorized Representative (sometimes known as an EC Rep or EC/CE Representative) is any person naturally or legally established in the European Community who is explicitly designated by the manufacturer to ensure compliance of their products. This person may be addressed by authorities and bodies within the European community, instead of the manufacturer themselves. In essence, an Authorized Representative is a legally required body for those located outside of the EU and looking to introduce medical devices to the European market.

Some of the key duties of an effective E.A.R. include:

  • Providing a registered address within the European Union
  • Keeping all technical documentation available for inspection by the European Authorities
  • Completing notifications to European Authorities
  • Completing any registrations to national databases
  • Taking care of any incident reporting
  • Representing the manufacturer towards the Competent Authorities
  • Safeguarding and ensuring compliance with constant regulatory updates
  • Consulting on European Regulations

 

What implications are there for non-measuring, non-sterile medical devices made outside of the European Union?

According to EU Medical Device Directive 93/42/EEF Article 14.2: “A manufacturer that does not have a registered address in the European Union may not make his medical devices available on the EU Market unless he first designated an Authorized Representative [or EAR] in the European Union.”

As a result of this, ALL manufacturers based outside the European Union (or without addresses within the bounds of the European Union) are obliged to appoint an E.A.R. with whom authorities can liase on issues regarding the the nature and quality of medical devices brought onto the European market.

While in cases of medical devices that are non-measuring and/or non-sterile (“self-declared” or otherwise; including bandages, stethoscopes, etc), manufacturers based within the European Union may be required simply to complete a technical file, all non-European Union-based bodies still must operate in conjunction with an E.A.R., regardless of classification or level of declaration.

Established in Brussels in 1988, the Obelis European Authorized Representative Center (O.E.A.R.C) provides European Authorized Representative and CE Marking advisory services to manufacturers all over the world in accordance with European Directives and Regulations. If you wish to learn more about the compliance process for medical devices or the CE marking, feel free to contact Obelis regulatory consultants!

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